Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000039583
Ethics application status
Approved
Date submitted
22/12/2014
Date registered
19/01/2015
Date last updated
18/03/2019
Date data sharing statement initially provided
18/03/2019
Date results information initially provided
18/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Frailty in intensive care (ICU) trauma patients: a prospective observational study.
Scientific title
An observational study of trauma ICU patients comparing frailty with age and co-morbidities in regards to mortality and morbidity.
Secondary ID [1] 285809 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Frailty
 293708 0
Trauma
 293709 0
Condition category
Condition code
Physical Medicine / Rehabilitation 294007 294007 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an observational study and therefore there are no interventions. Patients will be observed during their ICU stay and at 2 follow up time points (6 and 12 months post enrolment). The key outcomes are long term mortality and morbidity.
Intervention code [1] 290782 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293787 0
Mortality
Timepoint [1] 293787 0
12 months after enrolment
Secondary outcome [1] 311838 0
ICU mobility scale (IMS)
Timepoint [1] 311838 0
On awakening in ICU and at discharge from ICU
Secondary outcome [2] 311839 0
Medical Research Council Manual Muscle Test Sum Score (MRC-SS)
Timepoint [2] 311839 0
On awakening in ICU and at discharge from ICU
Secondary outcome [3] 311840 0
Mortality
Timepoint [3] 311840 0
In ICU, hospital and at 6 months after enrolment
Secondary outcome [4] 311841 0
Living situation (lives with family/friend, lives alone or other [nursing home, hospice etc]. This will be determined from questioning the participant or their person responsible.
Timepoint [4] 311841 0
At 6 and 12 months after enrolment
Secondary outcome [5] 311842 0
Return to employment
Timepoint [5] 311842 0
At 6 and 12 months after enrolment
Secondary outcome [6] 311843 0
Short form 12 (quality of life measure)
Timepoint [6] 311843 0
At 6 and 12 months after enrolment
Secondary outcome [7] 311844 0
EQ-5D (quality of life measure)
Timepoint [7] 311844 0
At 6 and 12 months after enrolment
Secondary outcome [8] 311845 0
GOS-E (functional outcome measure)
Timepoint [8] 311845 0
At 6 and 12 months after enrolment

Eligibility
Key inclusion criteria
Patients over 50 years of age.
Admitted to ICU under the trauma unit.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to communicate in English
Expected ICU length of stay <24 hours
Re-admission to ICU
ICU admission for palliation
Death is deemed imminent and inevitable
Unable to gain informed consent

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Statistical analysis will be completed using SAS version 9.3 (SAS Institute Inc., Cary, NC, USA). All available data will be analysed. Data will be assessed for normality and descriptive statistics will be presented as mean and standard deviations for normally distributed data and medians and interquartile range for non-normally distributed data. Continuous data will be compared using Student’s t-tests for normally distributed data and Wilcoxon rank-sum tests for non-normally distributed variables. Categorical data will be expressed as frequencies and percentages and will be compared using chi-square tests.

Patients will be dichotomised into two independent groups; frail and non-frail (frail, FP greater than or equals to 3 or CFS greater than 4 and non-frail, FP less than 3 or CFS less than or equals to 4). Survival for frail and non-frail patients will be analysed between groups using a log-rank test. Multivariable regression will be performed to identify the independent factors associated with ICU and six and 12 month mortality. Adjusted odds ratios (OR) and 95% confidence intervals (95% CI) of the OR will be calculated.

A two sided p-value of 0.05 will be considered statistically significant

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/04/2015
Actual
20/04/2015
Date of last participant enrolment
Anticipated
Actual
11/04/2017
Date of last data collection
Anticipated
11/04/2018
Actual
11/04/2018
Sample size
Target
200
Accrual to date
Final
138
Recruitment in Australia
Recruitment state(s)
WA,VIC

Funding & Sponsors
Funding source category [1] 290370 0
Hospital
Name [1] 290370 0
Alfred Hospital
Country [1] 290370 0
Australia
Funding source category [2] 290420 0
University
Name [2] 290420 0
Monash University
Country [2] 290420 0
Australia
Primary sponsor type
Individual
Name
Claire Tipping
Address
Physiotherapy Department
Alfred Hospital
Commercial Rd
Prahran, Vic 3004
Australia
Country
Australia
Secondary sponsor category [1] 289092 0
Individual
Name [1] 289092 0
Dr Carol Hodgson
Address [1] 289092 0
ANZIC-RC, DEPM, Level 6 Alfred Centre, 99 Commercial Rd, Melbourne, Vic 3004
Country [1] 289092 0
Australia
Secondary sponsor category [2] 289093 0
Individual
Name [2] 289093 0
Dr Anne Holland
Address [2] 289093 0
La Trobe University / Alfred Health Level 4, The Alfred Centre 99 Commercial Rd,
Melbourne VIC 3004
Country [2] 289093 0
Australia
Secondary sponsor category [3] 289094 0
Individual
Name [3] 289094 0
Dr Megan Harrold
Address [3] 289094 0
School of Physiotherapy & Exercise Science, Curtin University GPO Box U1987, Perth, WA 6845
Country [3] 289094 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292073 0
Alfred Hospital
Ethics committee address [1] 292073 0
Ethics committee country [1] 292073 0
Australia
Date submitted for ethics approval [1] 292073 0
26/11/2014
Approval date [1] 292073 0
09/01/2015
Ethics approval number [1] 292073 0
527/14

Summary
Brief summary
The elderly population in Australia is continuing to increase with the number of people over 65 years of age increasing from approximately 2.7 million in 2006 to 3 million in 2011. As people living longer they are exposed to a higher risk of trauma. Studies have shown that the elderly trauma population (over 65 years of age) have significantly higher mortality, increased ventilator days and longer ICU and hospital length of stay (LOS) compared to a younger population. Frailty is a widely used term to classify a multi-factorial syndrome comprising of physical and cognitive changes leading to increased vulnerability. Frailty is associated with increased risk of adverse events which are associated with higher cost of health care and care needs of patients. The prevalence of frailty amongst the critically ill population has been reported as 13% of all patients and 32.8% in patients over 50 years of age. Frail patients admitted to the intensive care unit (ICU) have been shown to have higher in-hospital mortality and lower quality of life at 6 month follow up. During the ICU admission, frail patients had more major adverse events and longer ICU and hospital LOS. There is no clear consensus on how to measure frailty, however two methods have been utilised in ICU research, the Phenotype Frailty (PF) and the Clinical frailty score (CFS). Historically elderly trauma patient outcomes have been investigated in relation to age and co-morbidities. This study aims to determine whether frailty is predictive of mortality and functional outcomes, which of two frailty measures is more effective at predicting mortality and functional outcomes and whether frailty is more effective at predicting mortality and functional outcomes compared to other patient measures (i.e. age, co-morbidities or injury severity score). METHODS: Prospective observational study, in 2 Australian ICUs (the Alfred Hospital and Royal Perth Hospital). We aim to recruit 200 patients admitted to ICU under the trauma unit, 50 years of age and over. Primary outcome measures include mortality (in ICU, hospital, 6 months and 12 months) and function using the GOS-E. Secondary outcome measure include (but not limited to) frailty, pre-morbid function, level of treatment in ICU, functional ability at ICU discharge.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53358 0
Miss Claire Tipping
Address 53358 0
Physiotherapy Department
Alfred Hospital
Commercial Rd
Prahran 3004
Melbourne Vic
Country 53358 0
Australia
Phone 53358 0
+ 61 3 9076 3450
Fax 53358 0
Email 53358 0
[email protected]
Contact person for public queries
Name 53359 0
Miss Claire Tipping
Address 53359 0
Physiotherapy Department
Alfred Hospital
Commercial Rd
Prahran 3004
Melbourne Vic
Country 53359 0
Australia
Phone 53359 0
+61 3 90763450
Fax 53359 0
Email 53359 0
[email protected]
Contact person for scientific queries
Name 53360 0
Dr Carol Hodgson
Address 53360 0
ANZIC-RC, DEPM, Monash University
99 Commercial Rd, Melbourne, Vic, 3004
Country 53360 0
Australia
Phone 53360 0
+61 3 9903 0598
Fax 53360 0
Email 53360 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseFrailty in Patients With Trauma Who Are Critically Ill: A Prospective Observational Study to Determine Feasibility, Concordance, and Construct and Predictive Validity of 2 Frailty Measures.2019https://dx.doi.org/10.1093/ptj/pzz057
N.B. These documents automatically identified may not have been verified by the study sponsor.